Cacaccio v. Mylan Pharmaceuticals, Inc. et al.

Mylan and Rite Aid are facing a class action that claims the companies respectively manufactured and sold generic valsartan medications despite possessing knowledge that the drugs were contaminated with probable carcinogen N-nitrosodiethylamine (NDEA).

The lawsuit follows Mylan’s November 20, 2018, announcement in which the company stated it was voluntarily recalling 15 lots of its valsartan-containing medications due to the FDA finding that several of Mylan’s products contained trace amounts of NDEA. Approximately two weeks later, the case notes, Mylan expanded the recall to “all non-expired lots of” its valsartan-containing high blood pressure medications.

According to the lawsuit, the defendants should have known Mylan’s valsartan medications were “likely contaminated” due to several previous recalls involving adulterated valsartan issued earlier this year by other pharmaceutical companies. The recalls, the case says, originally involved the possible presence of another carcinogen, N-nitrosodimethylamine (NDMA), in the valsartan drugs that was believed to be the result of the inadequate manufacturing practices of a Chinese supplier. Over the next few months, however, the recalls expanded to additional overseas laboratories in India, the suit says, including to those of Mylan’s manufacturers.

The stand-out allegation in the suit is that Mylan negligently failed to recall its products for more than four months after the initial recall involving valsartan manufacturers was announced. Perhaps worse, the lawsuit alleges the defendants intentionally remained silent in order to reap significant profits from patients who were switching from recalled products to Mylan products in the wake of the recalls. The case notes that during the same period, the price per tablet of valsartan medication “more than doubled,” allowing the defendants to further increase their earnings.

The lawsuit argues that the defendants harmed consumers by knowingly selling products that were essentially worthless and “unfit for human consumption” while profiting off false representations.

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